Patient-specific femoroacetabular impingement instruments and methods

ABSTRACT

A device for a patient-specific acetabular and/or femoral guide. The guides can be used in a selected resection of at least one of a femur and an acetabulum to increase a range of motion of the femur relative to the acetabulum. Generally, a natural acetabulum and femoral head are maintained.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/540,857, filed on Sep. 29, 2011. The entire disclosure(s) of (eachof) the above application(s) is (are) incorporated herein by reference.

INTRODUCTION

The present teachings provide patient-specific devices, which caninclude at least guides and implants, and methods for preparing one orboth of a femur and an acetabulum for a selected range of motion, andparticularly to increasing a range of motion of a natural femur withinan acetabulum.

SUMMARY

This section provides a general summary of the disclosure, and is not acomprehensive disclosure of its full scope or all of its features.

A system is disclosed that can be used to design instruments for andperform a procedure on a specific patient. A patient-specific device canbe a device that substantially matches a patient's anatomy, as discussedfurther herein, to perform a selected procedure on the patient. Thepatient-specific device is operable to conform to the anatomy of asingle patient for performing the selected procedure. In other words, asdiscussed further herein, the patient specific device includes at leasta surface that is designed to specifically engage the anatomy of asingle patient in substantially a single position and orientation basedon obtained information about a geometry of the single patient. This caninclude the contacting surface formed as a negative of a modeledpositive geometry of the single patient

The devices can include those that are operable to guide a mill orreamer instrument to remove a defect or abnormality from a selectedportion of the anatomy. For example, a femur's articulation with anacetabulum (also referred to as femoroacetabular impingement). Infemoroacetabular impingement, a femur, or a portion thereof, can have abone abnormality that impinges on a portion of the acetabulum defined bythe pelvis to limit a range of motion of the femur relative to thepelvis. Accordingly, a patient-specific device can be designed to assistin guiding or removal of a portion of at least one of the acetabulum orthe femur of the patient to assist in increasing a range of motion ofthe femur relative to the pelvis.

Further areas of applicability will become apparent from the descriptionprovided herein. The description and specific examples in this summaryare intended for purposes of illustration only and are not intended tolimit the scope of the present disclosure.

DRAWINGS

The drawings described herein are for illustrative purposes only ofselected embodiments and not all possible implementations, and are notintended to limit the scope of the present disclosure.

FIG. 1 is a detail environmental view of a patient with an identifiedfemoral articulation range limitation;

FIG. 2 is a flowchart illustrating a method of preparing a selectedpatient-specific guide system, according to various embodiments;

FIG. 3A is a surgeon input screen, according to various embodiments;

FIG. 3B is a view of a display device illustrating image data of apatient with a region to be removed;

FIG. 4A is a perspective exploded view of a reamer guide, according tovarious embodiments;

FIG. 4B is an interior perspective view of the reamer guide;

FIG. 5 is an environmental view of the reamer guide;

FIG. 5A′ is an environmental view of a lateral femoral neck reamerguide;

FIG. 5B′ is a bone contacting surface plan view of the lateral femoralneck reamer guide;

FIG. 6 is an environmental view of a template relative to a bone;

FIG. 7 is an environmental view of a template contacting a bone portion;

FIG. 8 is an environmental view of a second contact of the template tothe bone portion after further resection as compared to FIG. 7;

FIG. 9 is a perspective view of a greater trochanter resection guide,according to various embodiments;

FIG. 10 is a second perspective view of the greater trochanter resectionguide;

FIG. 11 is a bottom plan view of an acetabular resection guide,according to various embodiments;

FIG. 12 is a top environmental perspective view of the acetabularreamer; and

FIG. 13 is a top view of a kit of instruments and/or implants, accordingto various embodiments.

Corresponding reference numerals indicate corresponding parts throughoutthe several views of the drawings.

DETAILED DESCRIPTION

Exemplary embodiments will now be described more fully with reference tothe accompanying drawings.

The present teachings generally provide a patient-specific (custom)guide and method for a selected arthroplasty of a patient, includingpartial acetabular socket resection, partial femoral resection and/orreplacement or other similar procedure. More specifically, the presentteachings provide a patient-specific guide for the acetabulum of thepatient, when the acetabulum includes a defect that can be corrected bya partial socket resection or a partial implant. The present teachingsalso provide a patient-specific guide for the femur, including thefemoral head and/or femoral neck of the patient, when the femoral headand/or neck includes a defect that can be corrected by a partialresection or a partial implant. Generally, patient-specific guides arethose guides that are designed and manufactured based upon the specificanatomy geometry and configuration of a single selected patient. Thespecific geometry and configuration of the anatomy of the single patientis generally determined as discussed below (e.g. via modeling) and alsogenerally based upon specific instructions from an intended user and/orimplanter of the patient-specific devices.

Generally, patient-specific devices can be designed preoperatively usingcomputer-assisted image methods based on three- or two-dimensional imagedata of the patient's anatomy reconstructed from magnetic resonanceimaging (MRI), computed tomography (CT), ultrasound, X-ray, or otherthree- or two-dimensional medical scans of the patient's anatomy. Insome cases patient-specific device design can be complemented withdigital photography methods and/or anthropometry databases. Various CADprograms and/or software can be utilized for three-dimensional imagereconstruction, such as, for example, software commercially available byMaterialise USA, Plymouth, Mich.

Various alignment guides and pre-operative planning procedures aredisclosed in commonly assigned and co-pending U.S. patent applicationSer. No. 11/756,057, filed on May 31, 2007, U.S. patent application Ser.No. 12/211,407, filed Sep. 16, 2008; U.S. patent application Ser. No.11/971,390, filed on Jan. 9, 2008, U.S. patent application Ser. No.11/363,548, filed on Feb. 27, 2006; U.S. patent application Ser. No.12/025,414, filed Feb. 4, 2008, U.S. patent application Ser. No.12/571,969, filed Oct. 1, 2009, and U.S. patent application Ser. No.12/955,361, filed Nov. 29, 2010. The disclosures of the aboveapplications are incorporated herein by reference.

In the preoperative planning stage for a femoroacetabular resectionprocedure, imaging data of the relevant anatomy of a single specificpatient can be obtained at a medical facility or doctor's office, usingone of medical imaging methods described above. The imaging data caninclude, for example, various medical scans of a relevant joint portionor other relevant portion of the single specific patient's anatomy, asneeded for modeling, including three-dimensional (3D) modeling, furtherincluding 3D joint modeling. The image data can also be used,optionally, for implant alignment axis determination or for otheralignment purposes. The imaging data thus obtained and other associatedinformation can be used to construct a three-dimensional computer imageof the joint or other portion of the anatomy of the single specificpatient.

According to the present teachings, the patient-specific guides andimplants are generally configured to match the anatomy of the singlespecific patient and are generally formed using computer modeling basedon the single specific patient's reconstructed three-dimensionalanatomic image. The patient-specific guides have an engagement surfacethat is made to conformingly contact and match a three-dimensionalimage/model of a bone surface of the single specific patient's (with orwithout cartilage or other soft tissue), by the computer methodsdiscussed above. That is, a bone surface contacting surface of thepatient-specific guide is intended to be a negative or similar to amirror image of the bone surface of the single specific patient forwhich the patient-specific device is designed and manufactured. In thisrespect, a patient-specific guide can nestingly mate with thecorresponding bone surface (with or without articular cartilage) of thesingle specific patient in only one position.

According to the present teachings, the patient-specific guide caninclude a custom-made (patient-specific) guiding formation, such as, forexample, a mill guide for guiding a joint preparation tool, such as areamer, cutter, broach, mill, drill or other cutting tool, according tothe pre-operative plan for the patient. In some embodiments, the guidingformation can have a patient-specific size and shape configured duringpreoperative planning for the single specific patient to guide a millingtool, a reamer, a saw or other cutting tool, as discussed below. Thepreoperative plan can include planning for bone or joint preparation,including extent and area for defect removal, by milling, reaming,broaching or other cutting method, as well as implant selection andfitting. Also, a final or ideal range of motion can be selected.

The patient-specific guide described herein can be manufactured byvarious stereolithography methods, selective laser sintering, fuseddeposition modeling or other rapid prototyping methods. Thepatient-specific guide can be made of any biocompatible material,including metal, metal alloys or plastic. Generally, thepatient-specific guide is made of lightweight materials, includingpolymers. The patient-specific implant can, however, also include or beformed entirely of any biocompatible materials, including metals andalloys. The patient-specific guide, implant and associated tools can besterilized and shipped to the surgeon or medical facility in a kit for aspecific patient and surgeon for use during the surgical procedure. Thepatient-specific guides may then be disposed after the procedure forwhich the patient-specific devices were designed and planned. Thus, thepatient-specific devices as disclosed herein can be disposable or singleprocedure devices.

With reference to FIG. 1, an anatomy of a single specific patient (SSP)can include a pelvis 20 that defines an acetabulum 22. A femur 24 canarticulate within the acetabulum 22. Generally the femur 24 can includea femoral head 26 that defines an articular surface that articulateswith the acetabulum 22. A greater trochanter 26 extends from the femur24 and generally allows for soft tissue attachment to the femur 24.Extending between the greater trochanter 28 and the head 26 is a femoralneck 30. The neck 30 allows the head 26 to be positioned within theacetabulum 22 while the greater trochanter 28 and the body of the femur24 is positioned away from the pelvis 20 to allow for a range ofmovement of the femur 24 relative to the pelvis 20. The femoral neck 30,however, may include a defect or bone abnormality 32. The boneabnormality 32 can be congenital or develop over time due to disease orinjury. Regardless, the defect or abnormality 32 can impinge upon theacetabulum, such as near a rim or edge (e.g. a high portion 400 in FIG.9) of the acetabulum 22, to limit a range of motion of the femur 24relative to the pelvis 20. The range of motion of the femur 24 relativeto the pelvis 20 can be one that substantially limits motion of thefemur 24 relative to the pelvis 20 or one that causes discomfort in arange of motion of the femur 24 relative to the pelvis 20.

Regardless, the bone abnormality 32 can be selected to be removed. In aprocedure, a surgeon can obtain access to the patient's anatomy, such asthrough an incision, and through the surgeon's skill and experience,selectively remove a portion of the bone abnormality 32. Exemplaryprocedures are disclosed in Beaule, Paule et al., The Young Adult WithHip Impingement: Deciding on The Optimal Intervention, The Journal ofBone and Joint Surgery, Volume 91-A, #1, page 210-221, January 2009,incorporated herein by reference. As disclosed herein a femoralarticular impingement can be cured or relieved by removing a portion ofthe bone defect 32 as planned by a surgeon and with a patient-specificdevice regarding a single specific patient (SSP). The patient specificdevice can assist in removing a selected portion of the anatomy toachieve a selected or proposed result on the SSP. As described furtherherein, as illustrated in FIG. 2, a procedure 50 can be followed toobtain specific information of the SSP, plan a procedure, designpatient-specific devices for achieving the procedure, and selecting anappropriate result. Accordingly, the procedure 50 illustrated in FIG. 2can be used to generate patient-specific devices to achieve apatient-specific result as selected by a user.

Referring to FIG. 2, in preoperative planning, imaging data can beobtained of a selected portion of the SSP including an entire leg,further including a joint to be reconstructed at a medical facility ordoctor's office, at block 60. The imaging data can include a detailedscan of a hip, knee and ankle. The imaging data can be obtained usingMRI, CT, X-Ray, ultrasound or any other imaging system. In some cases,the scan may be performed with the SSP wearing an unloader brace tostress the ligaments. The scan data obtained can be sent to amanufacturer, at block 64. The scan data can be used by the manufacturerto construct a three-dimensional (3D) image of the selected joint. The3D image or 3D image data can be used to generate a 3D model that can beused to design and manufacture patient specific devices, as discussedherein. Generally, and depending on the procedure, an initial fitting,guiding, and alignment protocol detailing the fit of any implantcomponents and/or various alignment, milling, reaming and cuttinginstruments can be prepared. The fitting and alignment protocol can bestored in any computer storage medium (including a local or networkedhard disk drive or other stable or temporary storage medium), in acomputer file form or any other computer or digital representation. Theinitial fitting and alignment protocol can be obtained using standardalignment methods or using alignment methods provided by or based on thepreferences of individual surgeons.

As discussed above, in the preoperative planning stage of a surgicalprocedure, multiple image scans of portions of the SSP's anatomy relatedto the procedure are obtained. Image markers visible in the scan can beplaced on the SSP's anatomy to allow image scaling and orientation. Theobtained scans of the desired anatomy can be correlated to one anotherto reconstruct an image of the patient's specific anatomy inthree-dimensions.

The outcome of the initial fitting is an initial surgical plan createdat block 68 that can be printed or represented in electronic form withcorresponding viewing software. The initial surgical plan can besurgeon-specific, when using surgeon-specific alignment protocols. Theinitial surgical plan, in a computer file form associated withinteractive software, can be sent to the surgeon, or other medicalpractitioner, for review, at 72 (and viewable as a computer display 80in FIG. 3). Using the interactive software, the surgeon can manipulatethe position of images of various implant components (when used) and/oralignment/milling/reaming guides or other instruments relative to animage of the joint. Other modifications can include range of movementselections or general sizes and interactions of anatomical portions ofthe SSP. The surgeon can modify the plan and send it to the manufacturerwith recommendations or changes. The interactive review process can berepeated until a final, approved plan is sent to the manufacturer, at110.

Once the imaging scan has been used to collect scan data, includingimaging scan data, in block 60 and, as discussed above, the initialsurgical plan is sent to the surgeon in block 72. The initial surgicalplan can be viewed as illustrated in FIG. 3A. In FIG. 3A, a screen image80 is illustrated. The screen image 80 can include selected informationsuch as a surgeon's name, patient name, and other surgeon andpatient-specific information. A portion of the screen 80 can include afirst block or screen block 82 that describes a proposed femoral headdiameter. A second screen block 84 can illustrate a proposed minimalfemoral neck diameter. A third screen block 86 can describe a reamer orreamer size to be used.

The reamer to be used can include a radius size of the reaming portionor head of the reamer. The reamer size can be equal to a portion of theHead-to-Neck offset. The Head-to-Neck offset can be the differencebetween the diameter of the head and the diameter of the neck of thefemur to be resected. The size of the reamer can be about one third toabout two thirds, including about one half of the value of thedifference. As an example, the diameter of the head may be 40 mm and thediameter of the neck may be 24 mm, therefore the difference is 16 mm.The reamer size can be about one half the difference, or about 8 mm asillustrated in block 86.

The computer screen 80 can also include a fourth screen block 88 thatillustrates an α angle 90. The α angle 90 can be an angle between a line90 a from a center of the femoral head 26 down a center of the femoralneck 30 (e.g. the long axis of the femoral neck) to a line 90 b. Theline 90 b can be defined between the center of the femoral head 26 andan intersection of a circle defined by the center of the femoral head 26having a radius from the center to an edge of the spherical portion ofthe femoral head and where the circle intersects a non-spherical portionof the femoral head 26 by the femoral neck. The α angle 90 can be usedto illustrate a range of motion of the SSP after the initially proposedplan in block 72 and illustrated on screen 80.

In a fifth screen block 94, a center edge angle 96 is illustrated. Thecenter edge angle 96 is an angle between a first line 96 a that extendsfrom a center of the femoral head 26 to a superior rim of the acetabulum22 and a second line 96 b extending from the center of the femoral head26 substantially parallel with the long axis of the femur 24 or amechanical axis of the anatomy. The center edge angle 96 can also beused to assist in determining or designing various guide members, asdiscussed herein.

Finally, a sixth screen block 98 can illustrate a range of motion, fromvarious perspectives, for viewing by the surgeon based upon amodification of the SSP with the initially proposed plan or procedureand the instruments designed therefrom. Accordingly, the screen 80 is arepresentation of the initial surgical plan sent to the surgeon in block72. The initial surgical plan, as discussed above, is based upon thescan data sent to the manufacturer in block 64.

The six screen blocks 82-98 can be used to describe information receivedbased upon the imaging scan data sent to the manufacturer in block 64and information based upon the suggested or initially suggested sizes toachieve a selected range of motion within the SSP after the selectedprocedure. With continuing reference to FIGS. 2 and 3, the surgeon canfinalize, including changing and altering the initial plan, and sendingthe plan to the manufacturer in block 110 of the procedure 50. Thesurgeon can alter the plan by changing the α angle 90 in screen block 88and the center edge angle in screen block 94. The two angles can bealtered by inputs from the surgeon directly into a computer file that isincluded or that generates the screen 80 or sent separately forconsideration by the manufacturer. Additionally, the specific size orpositioning of various portions of the instruments, such as discussedherein including a reamer guide, can be altered by the surgeon whenfinalizing the initial plan. The surgeon can then send the finalizedplan to the manufacturer in block 110.

According to various embodiments the screen image 80 of a display devicecan also illustrate the image data of the patient with a planned removalregion 32′ illustrated, for example, with shading or varying colors asshown in FIG. 3B. The planned removal region 32′ can relate to thedefect 32 or any appropriate region to be removed based upon thefinalized plan. It is also understood that the planned removal region32′ may be shown to change based upon variations in the planning. Theplanned removal region 32′ can be used to design and manufacture anyappropriate device, as discussed further herein.

Various methods of sending the initial and final surgeon-approvedsurgical plans can be used. The surgical plans can be, for example,transferred to an electronic storage medium, such as CD, DVD, flashmemory, which can then be mailed using regular posting methods. Invarious embodiments, the surgical plan can be e-mailed in electronicform or transmitted through the internet or other web-based service.

Based upon the finalized plan in block 110, patient-specific devices arethen designed in block 120. The patient specific devices can includepatient-specific alignment/milling/reaming or other guides. The patientspecific devices for the SSP's joint can be developed using a CADprogram or other three-dimensional modeling software, such as thesoftware provided by Materialise, for example, according to the surgicalplan, at 120.

Patient-specific guides can then be manufactured and sterilized at 124.The guides can be manufactured by various stereolithography methods,selective laser sintering, fused deposition modeling or other rapidprototyping methods. In some embodiments, computer instructions of toolpaths for machining the patient-specific guides can be generated andstored in a tool path data file. The tool path can be provided as inputto a CNC mill or other automated machining system, and the alignmentguides can be machined from polymer, ceramic, metal or other suitablematerial. Patient-specific devices are defined as those constructed by asurgical plan, such as the finalized pan, approved by the doctor usingthree-dimensional images (including 3D models based on the image data)of the SSP's anatomy and made to closely conform and mate substantiallyas a negative mold to corresponding portions of the patient's anatomy,including bone surfaces with or without associated soft tissue, such asarticular cartilage, for example.

Images of the hip joint anatomy of the joint surface of the proximalfemur with or without the associated soft tissues, such as articularcartilage, on the respective bone surfaces can be used in the alignmentprocedure. The alignment procedure can include, for example, theselection of an anteversion angle, a femoral neck angle and otherorientations for positioning a femoral implant, such as a resurfacingcomponent, without notching or impinging on the femoral neck. Multiplealignment procedures can be provided to accommodate the experience andpreference of individual surgeons. For example, the alignment procedurecan be based on the anatomic and mechanical axes. Further, the alignmentprocedure can be deformity-specific in relation, for example, to variousdeformities and/or malformations of the hip joint anatomy, articulationand orientation.

The sterilized devices can be shipped to the surgeon or medicalfacility, at 126 for use during the surgical procedure. The sterilizeddevices, therefore, can be included in a single kit 450 (FIG. 10) fordelivery to a user, such as a surgeon, as a single unit. The sterilizeddevices also need not be kept in inventory at a place of use, but can bemanufactured and shipped on demand for a particular procedure on theSSP. It is also understood, that the patient specific devices need notbe sterilized prior to shipping, but that prior sterilization candecrease later processing at a facility of use of the patient specificdevices.

One of the patient specific devices to achieve the finalized plan fromblock 110 (including alignment and/or range of motion) can include afemoral neck reamer guide 200, as illustrated in FIGS. 4A, 4B, and 5.The femoral reamer guide 200 can be one of a plurality or the onlypatient-specific device designed, manufactured, and shipped (blocks 120,124, and 126) based upon the plan 50. Nevertheless, the portions of theneck reamer guide 200 are discussed herein.

Initially, the neck reamer guide 200 can also be referred to as amilling guide. Generally, the neck reamer guide 200 includes femurcontacting portion. The femur contacting portion can include a reamercap or dome portion 210 that includes a reamer interior or bonecontacting surface 212 that substantially mates with an articularportion of the femoral head 26 based upon the scan data sent to themanufacturer in block 64 of the procedure 50. The interior surface 212of the reamer guide 200 can include contours and geometries thatsubstantially mirror or form a negative relative to the shape of thearticular surface of the femoral head 26. Accordingly, the interiorsurface 212 can mate substantially tightly or nest substantially tightlyand in substantially only one configuration with the femoral head 26 ofthe SSP. In other words, the reamer interior surface 212 can be designedand manufactured to engage the femoral head of substantially only theSSP in a manner appropriate for guiding a reamer, as discussed herein.

Various portions can extend from the dome portion 210. A neck extensionfinger 220 that extends along the neck 30 of the femur 24 and can alsoextend down a portion of the shaft of the femur 24, if selected, canextend from the dome 210. The extension finger 220 can assist in furtherconformational holding of the reamer guide 200 relative to the femur 24.Thus, the finger 220 can include an anatomy contacting surface thatmirrors or is a negative of a selected portion of the femur 24.

To assist in holding the reamer guide 200 relative to the femur 24, pinsor screws can engage the femur 24. For example, a first screw 230 canpass through a first passage 232 in the extension finger 220 and engagethe femur 24. The screw 230 can extend at an angle that would passtowards the greater trochanter 28 of the femur 24. Additionally, asecond screw 236 can pass through a second passage 238 of the done 210and engage a fovea capitis of the femoral head 26. Generally, the foveacapitis can be engaged with a screw without substantially damaging thearticular region of the femoral head 26 due to the tissue attachment ofthe ligament teres between the femur 24 and the pelvis 20 within theacetabulum 22.

Accordingly, at least two screws 230 and 236 can be used to further fixthe reamer guide 200 to the femur 24 of the SSP. Nevertheless, thefemoral reamer guide 200 will substantially mate with the femur 24 ofthe SSP in substantially only one configuration or position due to thepatient-specific device nature of the reamer guide 200, which wasdesigned and manufactured based upon the scan data sent to themanufacturer in block 64. Thus, the guide 200 that is designed to assistin performing or carrying out the finalized plan procedure sent to themanufacturer in block 110 can ensure the completion of the procedurebased upon the finalized plan due to the patient-specific device natureof the guide 200 because the guide 200 will engage the femur 24 of theSSP in substantially one configuration to guide a mill or reamerinstrument 250 in substantially a single manner or path, as discussedherein.

The reamer instrument 250 that is guided with the guide body 200 ispositioned with an arm or member 260 that can include a first portion262 that extends from a pin or post 264. The pin 264 can extend from thedome portion 210 of the reamer guide 200 in any appropriate position.The first arm portion 262 can extend from the pin 264 in any appropriatemanner to allow for positioning of a second arm portion 266 relative tothe defect or bone abnormality 32 of the femur 24 such that the reamerinstrument 250 can be guided with the guide 200 relative to the defect32, generally in the direction of arrows 251 and 261, as discussedherein. The second arm portion 266 can be moved relative to the firstarm portion 262, such as via an articulation or pin connection 270. Thefirst arm portion 262 can be formed to be substantially rigid as can thesecond arm portion 266.

The articulating connection 270, therefore, can allow the second armportion 266 to include a guide engaging surface 272 to contact a guidesurface 274. The guide surface 274 can be formed with the reamer guide200 to allow the second arm portion 266 to glide or move along the guidesurface 274 to allow positioning of the reamer instrument 250 relativeto the bone defect 32 in a manner according to the finalized plan sentto the manufacture in block 110. The guide surface can further includeat least a first stop surface 276. The second guide arm portion 266,therefore, can move along the guide surface 274 until it engages thefirst stop 276. The guide 200 can further include a second stop portion278.

Accordingly, the reamer guide 200 can define an arc, shown as arrow 261that defines a range of movement of the second arm portion 266 relativeto the pin 264. Thus, the guide arm 260 can guide the reamer instrument250 along the arc 261 to remove the bone defect 32 in a selected manner.The reamer can also move in the direction of arrow 251 generally axiallywithin the arm 260. An angle, length, and other geometric features ofthe arc 261 and the length of position of the arrow 251 relative to thedefect 32 and the other portions the femur 24 can be designed based uponthe finalized plan sent to the manufacturer in block 110, which isinitially based upon the scanned data sent to the manufacturer in block64. Accordingly, the reaming configuration that is defined by the guidesurface 274, the two stops 276 and 278, the position of the pin 264, theconfiguration of the first arm portion 262 relative to the pin 264 andthe articulation connection 270 and the surface 272 of the second armportion 266 all cooperate to ensure an appropriative configuration ofmovement of the reaming or milling instrument 250 relative to the femur24. As discussed above, the guide 200 is positioned relative to thefemur 24 in substantially a single configuration or position due to thepatient-specific nature of the reamer guide 200. Thus, the reaming ofthe defect 32 of the femur 24 is also substantially patient-specific tothe SSP to ensure a selected result based upon the scanning data.

The reamer instrument 250 can be powered by any appropriate instrument,such as a drill motor 290. The drill motor 290 can be powered oroperated by a surgeon to power the milling instrument 250 during themilling or reaming procedure. The movement of the reamer instrument 250,however, relative to the guide 200, can be based upon a force providedby the surgeon by moving the guide arm 260 along the surface 274 andbetween the two stops 276 and 278.

According to various embodiments, a lateral femoral neck reamer guide200′ can also be provided or be provided as an alternative to thefemoral neck reamer guide 200. The lateral femoral neck reamer guide200′, as exemplary illustrated in FIGS. 5A′ and 5B′ can include portionsthat are similar to the femoral neck reamer guide 200 and these portionscan include the same reference numerals augmented by a prime. Generally,the lateral femoral neck reamer guide 200′ can include a guide portion210′ that is able or formed to contact or be positioned near a lateralportion of the femur 24, such as near the greater trochanter (which isshow resected in FIG. 5A′ as discussed further herein) and/or a shaft 24a of the femur 24.

The lateral femoral neck guide 200′ can also be the defect reamer guide,as discussed above and herein. The lateral guide 200′, however, can beaffixed to a lateral surface of a portion of the femur 24. For example,the lateral guide 200′ can include a first extension portion 201′ thatcan extend along a portion of a shaft 24 a of the femur 24. A guide orguiding portion 210′ can also be positioned relative to a lateralportion of the femur 24, and contact a portion of the shaft 24 a or aportion of the greater trochanter 28 or resected greater trochanter, asillustrated in FIG. 5A′. Nevertheless, the lateral reamer guide 200′ caninclude portions similar to the reamer guide 200, as discussed above,and be designed to resect a portion of the femoral neck 30, includingthe defect 32.

The lateral guide 200′ can include also include a bone contactingsurface 212′ that is an interior surface, as illustrated in FIG. 5B′.The bone contacting surface 212′ is formed to include contours thatsubstantially match at least a portion of the femur 24, such as alateral surface of the femur 24 a and the greater trochanter 28. Thebone contacting surface 212′ can extend along the shaft portion 201′ andin the trochanter contacting portion 210′. The contours cansubstantially match or form a negative or mirror image of the femur 24to assist in positioning the lateral reamer guide 200′ relative to thefemur 24 for resecting the femur 24, according to the final plan.Accordingly, the lateral guide 200′ can be positioned relative to thefemur 24 to position a reamer for reaming the defect 32 according to aprocess similar for the guide 200, as discussed above.

The lateral reamer guide 200′ can further include holding portions orfixing portions. A first screw 230′ can pass through a first passage232′ and a second screw 236′ to pass through a second passage 238′. Thescrews or other fixation portions can assist in fixing the lateral guide200 relative to the femur 24 during guiding of the reamer 250 relativeto the femur 24.

Additionally, extending from the dome or guiding portion 210′ can be apin 264′ that can engage a portion of a guide arm 260′ to allow theguide arm 260′ to generally move in at least a portion of an arc 261′defined by the guide 200′. Similar to the guide 200, discussed above,the guide 200′ can include a guide surface 274′ and a second guide armportion 266′ can include a guide surface to engage the guide surface274′ of the guide 200′. A first arm portion 262′ can extend an engagethe second arm portion 266′ at a hinge or flexing portion that caninclude a connection pin 270′.

The second arm portion 266′ can also include a holding or guidingportion to hold the reamer 250 and also allow the reamer 250 to moveaxially generally in the direction of arrow 251′ relative to the secondguide arm portion 266′ and the guide 200′. Accordingly, the guide 200′including or in operating the guide arm 260 can move or guide the reamer250 for reaming a selected portion of the femur 24, such as the defect32. It will be understood that the reamer 250 can be powered with adrill motor 290, as discussed above.

Additionally, the position of the guide surface 274′ can be developedbased upon the final plan as discussed above. The guide surface 274′ canalso be stopped or limited by first and second stop portions 276′ and278′. The stop portions 276′ and 278′ limit movement of the second guidearm 266′ along the guide surface 274′ so that the guide arm 260′ movesrelative to the femur 24 based upon the design of the lateral guide 200′to resect the defect 32 or selected portion of the femur 24 based uponthe final plan.

Accordingly, it will be understood, that the reamer 250 can be guidedrelative to the femur 24 with a selected patient specific guide ordefect guide that can be positioned relative to the femur 24 in anappropriate manner. For example, the guide 200 can be positioned overthe femoral head to guide the guide arm 260 relative to the femur 24. Inaddition, or alternatively thereto, the lateral guide 200′ can bepositioned in a lateral portion of the femur 24 to guide the reamer 250relative to the femur 24. It will be further understood that based upona selected resection, two resection guides may be selected to achieve aselected amount of resection femur 24. For example, if a plurality ofcuts or a complex angle is required or selected to resect the femur 24in a selected manner, a plurality of the guides can be positioned on thefemur 24 in a plurality of positions to achieve the selected resection.

As an alternative to the reamer guides 200, 200′ discussed above, apatient specific bone removal template 299, as illustrated in FIGS. 6-8,can be designed and manufactured to instruct a surgeon on the bone to beremoved from the femur 24. As discussed above, the femur 24 can includethe defect 32 that can be modeled and/or determined in the image data asthe region to be removed 32′. The region to be removed 32′ can be usedto generate a 3D model and further used to instruct (e.g. via a CADmodel for manufacturing) a milling or 3D manufacturing machine tomanufacture the template 299 based on the determined region to beremoved 32′

The template 299 can include a handle portion 301 to allow for graspingby a user, such as a surgeon. The handle 301 can interconnect with atemplate region 302 that has been specifically designed to match apatient and to indicate tissue to be removed. As discussed above, thebone removal region 32′ can be based upon the defect 32 of the femur 24.According to various embodiments, the template region 302 of thetemplate 299 can be an inverse of the bone removal region 32′ such thatwhen the bone removal region 32′ has been removed from the femur 24 thatthe template region 302 will contact the remaining femur portion 24 tosubstantially mimic the region to be removed 32′. To assist in referenceor determining an appropriate amount of removal, reference fingers ortangs 304 a-304 d, can also be provided to engage regions of the femur24 that are not intended to be removed. For example, the tangs 304 a and304 b can contact regions of the neck 30 or the head 26 while thefingers 304 c and 304 d can contact regions around the greatertrochanter 28. The template region 302, therefore, can be positioned tocontact the femur 24 during portions of the bone removal procedure toassist the surgeon in determining whether an appropriate amount of bonehas been removed.

With continuing reference to FIG. 6 and additional reference to FIGS. 7and 8, a reamer 306, can be powered by a drill motor 308 that isoperated by the surgeon to remove the bone defect 32. The reamer 306 canbe operated to remove the bone defect 32 in incremental portions, suchas about 1 or 2 mm layers per pass, such that the template 299 can becontacted to a bone resection region 32 a after each pass or at aselected time to ensure that the selected amount of bone has beenremoved. It is understood, however, according to various embodiments,that a surgeon can determine that additional or less bone can be removedintraoperatively and uses the template 299 as a guide. As illustrated inFIG. 7, after a selected period of time, the template 299 can becontacted near the bone resection region 32 a.

As illustrated in FIG. 7, if the template 299, including the templateregion 302 does not rest appropriately, such as flushly, with thesurrounding bone surface around the bone resection region 32 a, thenresection can continue with the reamer 306 by the surgeon. After anadditional portion of resection, the template 299 can be placed adjacentthe bone resection region 32 a again, as illustrated in FIG. 8, toconfirm that the template region 302 of the template 299 restssubstantially adjacent and/or in contact with the surrounding bone.Again, the positioning tangs 304 a-d can be used to assist in confirmingpositioning of the template 299 relative to the adjacent portions ofbone to ensure that the template region 302 is in the selected andappropriate position.

The template region 302 is based upon the determination of the region tobe removed 32′ determined in the plan 50, discussed above. Accordingly,the device designed in block 120 can be the template 299 that is basedupon the final surgeon plan in block 110. The template region 302 can bebased upon the determination of the volume and position of bone thatneeds to be removed or is determined to be removed to achieve theselected movement of the femur 24. Accordingly, the template 299 cancontact the bone at the bone resection region 32 a to assist inconfirming and determining an appropriate amount of bone to be removed.

It is understood that an opening or incision in the patient can allowfor access to the femur 24 with the template 299 and that the same ordifferent opening can be used to allow access of the reamer 306 to thefemur 24 for resection. Accordingly, the bone can be resected at anappropriate rate and time until the template region 302 of the template299 contacts the bone appropriately, such as flushily or with adetermined clearance or contact amount. It is also understood that thetemplate 299 can be used in conjunction with either of the guides 200 or200′ discussed above to ensure an appropriate amount of the bone hasbeen removed. Accordingly, once the selected guide 200 or 200′ has beenused to resect an appropriate or selected portion of the bone, thetemplate 299 can be used to confirm or fine tune any selected resection.

A second type of a patient specific device can include a greatertrochanter guide 370 as illustrated in FIGS. 9 and 10. Accordingly, thetrochanter guide 370 is a patient-specific device. The trochanter guide370 can be designed and manufacturer based upon the scanned data sent tothe manufacture in block 64 and the finalized plan sent to themanufacturer in block 110. The trochanter guide 370, therefore, cansubstantially mate with and contact a specific anatomy, including thegreater trochanter 28 of the femur 24 of the SSP. Illustrated in FIGS. 9and 10 is the femur 24 with no soft tissue surrounding the femur 24. Itis understood by one skilled in the art, however, that soft tissue canbe connected to the greater trochanter 28 as illustrated in FIG. 1. Toallow for positioning of the reamer guide 200 on the femoral head 26,the greater trochanter 28 can be resected from the remaining portions ofthe femur 24 prior to dislocating the femur 24 from the acetabulum 22.The soft tissue connected to the greater trochanter 28, therefore, neednot be stretched or moved substantially relative to the pelvis 20 andthe acetabulum 22 when dislocating the femur 24 from the acetabulum 22to perform the resection on the femur 24 and a resection to theacetabulum 22, as discuss further herein. Additionally, the greatertrochanter guide 370 can be used to guide fixation pins or screw holesinto the greater trochanter 28 relative to the femur 24 for reattachmentof the greater trochanter 28 to the femur 24 after resecting the bonedefect 32.

The trochanter guide 370 can include any appropriate size or area tocontact the femur 24. Generally, the trochanter 370 can include a bonecontacting surface 372 to contact the femur 24 in a substantiallypatient-specific manner. The contact surface 372 of the trochanter 370can include a geometry that is substantially a mirror image or anegative of a portion of the femur 24. Accordingly, the trochanter guide370 that is a patient-specific device can contact the SSP insubstantially a single configuration or position to allow for resectingthe greater trochanter 28 in a single selected manner. Generally, themating and nesting of the greater trochanter 370 relative to the femur24 is enough to maintain positioning of the trochanter 370 relative tothe femur 24 for the resection and drilling procedures.

Once the access is made to the femur 24, the greater trochanter guide370 can be positioned on the femur 24, as exemplarily illustrated inFIGS. 9 and 10. A plurality of bores, as exemplarily illustrated asthree bores, can be drilled through three drill guide passages 374, 376and 378 in a drill guide section 380 of the trochanter guide 370. Thedrill guide 380380 can allow for the drilling of passages 382, 384, and386 through the greater trochanter 28 and through the remaining portionof the femur 24. Generally, the passages 382, 384, and 386 can besubstantially through the femur 24 to allow for a purchase of a screw ora bolt into cortical bone that is substantially opposite the beginningor entry of the passages into the greater trochanter 28. The passages382-386 can generally extend from the greater trochanter 28 to withinthe region 388 of the femur 24 generally near, such as slightlysuperior, the lesser trochanter 390.

After resection of the greater trochanter and resection of the bonedefect 32, the greater trochanter 28 can then be reattached to the femur24 with appropriately length screws or bolts. The passages 382-386 canbe used to substantially precisely reattached the greater trochanter 28to the femur 24. The lengths of the screws can also be determined priorto the procedure based upon the scan data sent to the manufacture inblock 64. In determining the length of the screw prior to the procedureonly an appropriate length screw can be provided as a portion of thepatient-specific kit. Also, intra-operative measuring may not benecessary to ensure appropriate fixation of the screws through thegreater trochanter 28 and into cortical bone substantially opposite thegreater trochanter 28. Also, the number of screws may be limited in thekit as only one length can be provided, thus reducing cost per kit orcleaning of unused screws after a sterile seal is broken.

Once the screw passages 382-386 are drilled into the femur 24, aresection of the greater trochanter 28 can be performed at asubstantially preplanned and precise position by using a cut guide slot392 formed into the greater trochanter guide 370. The trochanter cutguide slot 392 can be positioned relative to the femur 24 based upon thepatient-specific nature of the greater trochanter guide 370 to ensure anappropriate resection of the greater trochanter 28. An appropriateresection can include substantially no resection or limited disruptionof any soft tissue connected to the greater trochanter 28, whileensuring an appropriate amount of bone in the resection to allow for anappropriate reattachment of the greater trochanter 28 to the femur 24.An appropriate instrument can be used to perform the resection such as asaw blade, including a reciprocating saw generally understood by oneskilled in the art. An appropriate saw can include a reciprocating sawblade generally used for bone resection as generally understood by oneskilled in the art. Once the resection of the greater trochanter 28 iscompleted, the trochanter guide 370 can be removed from the femur 24.Additionally, once the greater trochanter 28 is resected, the femur 24can be dislocated from the acetabulum 22. Once the femur 24 isdislocated from the acetabulum 22, the defect milling guide 200 and/or200′ can be connected to the femur 24 and/or femoral head 26 to allowfor a resection or removal of the selected bone defect 32.

With reference to FIGS. 11 and 12, the acetabulum 22 can also be aportion of the diagnosis of the femoral acetabulum impingement on thefemur, such as on the defect 32, can be determined. For example, a rimor upper portion or exterior portion of the acetabulum 22 can includeportions that are substantially high relative to an internal portion ofthe acetabulum. A high rim portion 400 can extend beyond a low rimportion 402, relative to each other, and relative to a deep or internalportion of the acetabulum 22. The high rim portion 400 can be a distance401 higher than an upper rim portion 420 of the acetabulum guide 410.Accordingly, an acetabulum cut guide 410 can be patient specific deviceas designed and manufactured to be seated or positioned within theacetabulum 22.

The acetabulum cut guide 410 can include the upper rim portion 420 thatis connected to a central deep or low portion 422 with spokes orextension arms 424. It is understood that the acetabulum cut guide 410can also be substantially solid rather than including a plurality ofconnection spokes 424, but the connection spokes that define the openareas 426 can assist in minimizing material, weight, and impingement onarticulation portions of the acetabulum 22.

The acetabulum cut guide 410 can include a bone contacting surfacedefined at least by an exterior surface 430 of the extending spokes, anexterior surface 432 the rim 420, and an exterior surface 430 of thecentral portion 422. The bone contacting surfaces 430, 432, and 434allow the acetabulum cut guide 410 to be positioned within theacetabulum 22 of the SSP in a substantially single configuration andposition. Again, the geometry or configuration of the acetabulum 22 canallow for the design and manufacturer of the cut guide 410 in asubstantially single configuration to engage the acetabulum 22 in asubstantially single manner. Thus, the acetabulum cut guide 410 can beformed in a patient-specific manner to engage the acetabulum 22 of theSSP in a substantially single configuration.

Once the patient-specific acetabulum cut guide 410 is positioned withinthe acetabulum 22 of the SSP, an instrument can be used to engage anupper or cut guide surface or guide surface 440 of the rim 420. As thecutting or reaming instrument engages the upper surface 440 of the rim420, the high regions 400 from around the acetabulum 22 can be removed.Thus, the upper edge or rim of the acetabulum 22 can be substantiallyminimized to achieve an appropriate range of motion of the femur 24relative to the pelvis 20.

Accordingly, the reamer guide 200 and the acetabulum cut guide 410 canbe formed in a substantially patient-specific manner including variousconfigurations and materials as discussed above. The defect reamer guide200 and the acetabulum cut guide 410 can be used individually ortogether to achieve the planned range of motion in the SSP. It will beunderstood that in selected patients, only the bone defect 32 reduces orminimizes the range of motion of the femur 24 relative to the pelvis 20.Accordingly, in various patients the finalized plan sent to themanufacture in block 110 need not include information that requiresresection of a portion of the acetabulum 22. For example, if the CenterEdge angle 96 is determined to be within an appropriate range, such asgreater than about 40 degrees, an acetabular reamer guide 410 may not benecessary and therefore, not designed or provided. Nevertheless, thefinalized plan sent to the manufacturer in block 110 can includeinformation for forming or designing the defect reamer guide 200 and theacetabulum resection guide 410 to achieve a selected range of motion ofthe femur 24 relative to the pelvis 20. Additionally, the greatertrochanter guide 370 can be designed in the patient-specific manner asdiscussed above, to allow resection of the greater trochanter tominimize or reduce any stretching of soft tissue connected to thetrochanter during dislocation of the femur 24 to position the mill guide200 relative to the femoral head 26.

As discussed above, all of the guides, including the reamer guide 200,the template 299, the greater trochanter guide 370, and the acetabularresection guide 410 can be formed of materials that are relativelyinexpensive, and can be used for a single procedure on the SSP.Generally, the guide patient-specific devices can be used on the SSP inperforming the planned procedure and then discarded. In discarding thepatient-specific devices, it can be ensured that the patient-specificdevices are specific to the SSP to achieve a planned result.Additionally, chances of cross contamination from one patient to anotherdue to reuse of the instrument can be substantially eliminated.Additionally, a requirement of maintaining a selection and inventory ofinstruments and guides and labor and instrumentation for cleaninginstruments and guides is not required by a facility. Generally, thepatient-specific devices can be formed for each procedure based upon thedata provided to the manufacture that is based on the SSP and then thepatient-specific devices can then be discarded.

It is also understood that all of the guides 200, 200′, 370, and 410along with the template 299 can be provided to together as a single kit450 to the surgeon, along with the ancillary portions including thereamer 250 and pins 230 and 236. Also, the kit 450 can include anyimplants, such as screws 452 to fit in the passages 382-386. Thus, theentire kit 450 can be provided to a surgeon as illustrated in FIG. 13.The kit 450 can be sterilized and sent to the surgeon in block 126. Itwill be further understood, however, that the kit 450 need not includeall portions. For example, the kit 450 may only include one of thefemoral defect guides 200, 200′, or 299. In an alternative the kit 450may include at least two or three of the guides for selection by thesurgeon intraoperatively of the guide and/or template to be used. Also,the kit 450 may not include the acetabular guide 410. IN addition, thekit need not include the greater trochanter cut guide 370. For example,the surgeon may free hand cut the greater trochanter 28. If the greatertrochanter guide 370 is not included, the screws 452 can be included foruse in fixation of the resected greater trochanter 28 even if resectedwithout the guide 370. Thus, some portions are optional, but may also beincluded in the kit 450.

It will be apparent to those skilled in the art that specific detailsneed not be employed, that example embodiments may be embodied in manydifferent forms and that neither should be construed to limit the scopeof the disclosure. In some example embodiments, well-known processes,well-known device structures, and well-known technologies are notdescribed in detail. Accordingly, individual elements or features of aparticular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

What is claimed is:
 1. A system to resect a selected portion of ananatomy to improve a range of motion of a femur relative to a pelvis ina specific patient, comprising: a femoral neck resection guideincluding: a reamer cap comprising a bone contacting surface that mateswith a surface of the femur and a dome-shaped exterior surface oppositethe bone contacting surface such that the bone contacting surface isdisposed at least partially within the reamer cap; a pin extending fromthe exterior surface; a guide surface defined by at least a portion ofthe exterior surface; and a guide arm moveably connected to the pinincluding a guide arm surface configured to contact the guide surfaceduring movement of the guide arm relative to the exterior surface;wherein the guide arm includes a mill passage to engage a millinstrument that is configured to resect the selected portion of thefemur.
 2. The system of claim 1, wherein the guide arm includes a firstguide arm portion and a second guide arm portion with an articulationconnection between the first guide arm portion and the second guide armportion; wherein the second guide arm portion is operable to moverelative to the first guide arm portion; the first guide arm portion isfreely rotatable about an entirety of the reamer cap when the secondguide arm portion is disengaged from the guide surface; and the firstguide arm portion is rotatable about only a portion of the reamer capwhen the second guide arm portion is engaged with the guide surface. 3.The system of claim 2, further comprising: a milling instrumentconfigured to engage the second guide arm portion via the mill passage;wherein a movement of the milling instrument is operable to moverelative to the pin.
 4. The system of claim 3, wherein the guide surfacedefines an arc having a center at the pin, wherein the millinginstrument is operable to move in an arc substantially equivalent to theguide surface arc to mill a portion of the femoral neck.
 5. The systemof claim 4, wherein the first guide arm portion extends from the pin andthe second guide arm portion extends at a non-zero angle relative to thefirst guide arm portion; wherein the second guide arm portion definesthe guide arm surface.
 6. The system of claim 4, wherein the millinstrument is operable to move axially along the mill passage.
 7. Thesystem of claim 6, wherein the mill instrument is operable to move in apatient specific milling movement due to the guide surface, the millpassage, and the guide arm surface.
 8. The system of claim 1, furthercomprising: a greater trochanter guide including an anatomy contactingsurface that is a negative of and operable to contact an anatomy of thespecific patient in a substantially single position, wherein the greatertrochanter guide includes: a cutting guide slot configured to bepositioned at a patient specific location relative to the femur of thepatient; and a drill guide portion operable to orient a drill guidepassage at a specific location relative to the femur of the patient. 9.The system of claim 1, wherein the bone contacting surface that mateswith a surface of the femur mates with at least one of a femoral head ora greater trochanter.
 10. The system of claim 1, further comprising: apatient specific acetabular cutting guide including an anatomycontacting surface that is a negative of an anatomy of the specificpatient and to engage the anatomy of the patient in a substantiallysingle position, the patient specific acetabular cutting guide having anouter surface that is the anatomy contacting surface to engage anacetabulum of the patient and an upper rim to define a cutting guidesurface to resect a portion of the acetabulum in which the patientspecific acetabular cutting guide is placed.
 11. The system of claim 1,further comprising: a patient specific tissue removal template having atemplate region shaped to an inverse of a predetermined region of tissueto be removed.
 12. The system of claim 11, wherein the patient specifictissue removal template has the template region shaped to match aportion of a determined resection shape at a femoral neck of theanatomy.
 13. The system of claim 11, wherein the patient specific tissueremoval template further includes femur contacting tangs to align thetemplate region relative to the femur of the anatomy.